A Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00885963
First received: March 31, 2009
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

This is an open label, single arm, phase II study to evaluate the safety and efficacy of oral sapacitabine administered twice daily for 5 consecutive days every week for 2 weeks followed by 7-day rest in patients who have had one prior chemotherapy regimen for advanced Non-Small Cell Lung Cancer (NSCLC).


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: sapacitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Cyclacel Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • the rate of response and stable disease [ Time Frame: after cycle 2, 4, 7 and every 3 cycles thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression-free survival [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
  • duration of response [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
  • duration of stable disease [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]

Enrollment: 62
Study Start Date: December 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sapacitabine Drug: sapacitabine
twice daily by mouth for 7 days or once daily by mouth for 5 days/week x 2 weeks every 21 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed recurrent NSCLC
  • Age of 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Measurable disease according to RECIST
  • Had only 1 prior chemotherapy regimen for metastatic or recurrent disease; patients who have received more than one prior chemotherapy regimens may participate in Part A of the study only.
  • Adequate bone marrow function
  • Adequate renal function
  • Adequate liver function
  • At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy; at least 7 days from prior radiation therapy; and have recovered from prior toxicities
  • At least 3 weeks from major surgery
  • Patient must be able to swallow capsules
  • Agree to practice effective contraception during the entire study period and for one month after being discontinued from the study unless documentation of infertility exists. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

  • NSCLC histology contains a component of small cell lung cancer
  • Previously untreated CNS metastasis or progressive CNS metastasis documented by MRI scan performed at 4 weeks or longer after the last treatment for CNS metastasis
  • Currently receiving radiotherapy, biological therapy, or any other investigational agents
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Cancer other than NSCLC that has been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer, and basal or squamous cell skin cancer; patients who received only hormonal therapy in the neoadjuvant or adjuvant setting in the past 5 years may participate in this study
  • Pregnant or lactating women
  • Known to be HIV-positive
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885963

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Investigators
Study Chair: Philip Bonomi, M.D. Rush University Medical Center
  More Information

No publications provided

Responsible Party: Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00885963     History of Changes
Other Study ID Numbers: CYC682-08
Study First Received: March 31, 2009
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014